Statutory Instruments
2008 No. 2297
Medicines
The Veterinary Medicines Regulations 2008
Made
26th August 2008
Laid before Parliament
1st September 2008
Coming into force
1st October 2008
The Secretary of State is a Minister designated( 1 ) for the purposes of making Regulations under section 2(2) of the European Communities Act 1972( 2 ) in relation to measures in the veterinary and phytosanitary fields for the protection of public health.
The Secretary of State has carried out the consultation required by Article 9 of Regulation 3 ).
In accordance with section 56(1) of the Finance Act 1973( 4 ), the Treasury consent to the making of these Regulations.
The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of the European Communities Act 1972 and by section 56(1) of the Finance Act 1973.
PART 1 Introduction
Title and commencement
1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Definition of “veterinary medicinal product”, interpretation and scope
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Products to which these Regulations do not apply
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 2 Authorised veterinary medicinal products
Placing a veterinary medicinal product on the market
4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Manufacture of veterinary medicinal products
5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The finished product
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Classification, supply and possession of the product
7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Administration of the product
8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Importation of authorised veterinary medicinal products
9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Advertising the product
10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Advertising of prescription products and products containing psychotropic drugs or narcotics
11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Defence of publication in the course of business
12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Wholesale dealing
13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Feedingstuffs
14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Exemptions
15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fees
16. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 3 Records
Food-producing animals: proof of purchase of veterinary medicinal products
17. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Food-producing animals: records of administration by a veterinary surgeon
18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Food-producing animals: records of acquisition and administration
19. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Food-producing animals: retention of records
20. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records by a holder of a manufacturing authorisation
21. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records by a holder of a wholesale dealer’s authorisation
22. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records of the receipt or supply of prescription products
23. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Records of products administered to a food-producing animal under the cascade
24. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 4 Unauthorised veterinary medicinal products
Importation of an unauthorised veterinary medicinal product
25. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Possession of an unauthorised veterinary medicinal product
26. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Supply of an unauthorised veterinary medicinal product
27. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PART 5 Miscellaneous provisions, enforcement and offences
The Veterinary Products Committee
28. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Veterinary Products Committee appeals procedure
29. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appeals to an appointed person
30. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Exports
31. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Time limits
32. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appointment of inspectors
33. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Powers of entry
34. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Powers of an inspector
35. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection of pharmacies
36. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Obstruction
37. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Improvement notices
38. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appeals against improvement notices
39. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Powers of a court on appeal
40. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Seizure notices
41. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Publication
42. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Penalties
43. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Northern Ireland
44. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Revocations and consequential amendment
45. — (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(2) In section 1 of the Medicines Act 1971( 5 ) (fees), in subsection (3), for “as amended by the Transfer of Functions (Wales) Order 1969 have the same meanings in this section as in that Act as so amended” substitute “(as amended) have the same meanings in this section as in that Act (as amended)”.
Jonathan Shaw
Parliamentary Under Secretary of State
Department for Environment, Food and Rural Affairs
Dave Watts
Alan Campbell
Two of the Lords Commissioners of Her Majesty’s Treasury
Regulation
SCHEDULE 1 Marketing authorisations
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation
SCHEDULE 2 The manufacture of veterinary medicinal products
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation 7
SCHEDULE 3 Classification and supply, wholesale dealers and sheep dip
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation 8
SCHEDULE 4 Administration of a veterinary medicinal product outside the terms of a marketing authorisation
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation 14
SCHEDULE 5 Medicated feedingstuffs and specified feed additives
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation 15(4)
SCHEDULE 6 Exemptions for small pet animals
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation 16
SCHEDULE 7 Fees
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
OJ No. L31, 1.2.2002, p. 1.
1971 c.69 , as amended by section 21 of the Health and Medicines Act 1988 (c. 49) and S.I. 1994/3144 , 2004/1031 , 2005/2750 and 2006/2407 .